Site Name: Bengaluru Luxor North Tower
Posted Date: Apr 30 2024

• Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
• Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements.
• Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide.
• Demonstrated effectiveness in management of projects of increasing scope and complexity.
• Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome).
• Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective plans for solutions.
• High-level technical, statistical, and computer skills, and the ability to interpret complex clinical data.
• Assess trends and patterns in text and statistical data, and effectively organizes content and messages in clinical reports and summary documents.
• Review reporting and analysis plans and provides critical input on the content and display of tables.
• Familiarity with approaches to expedite document preparation such as review tools and automation.
• Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment (e.g., ability to support documents in different therapeutic areas).
• Effectiveness in both oral and written communications.

Job Related Experience (Minimum Requirement):

• PhD or relevant working experience within the life sciences space.
• 6 to 10 years of experience.
• Clinical regulatory writing experience in the pharmaceutical industry
• Demonstration of leadership.
• Experience in multicultural settings (to reflect our external customers/clients [health authorities/patients] and diverse environments with respect to dynamics of human interaction (including working with remote teams)
• Ability to interpret, describe and document clinical data.
• Working knowledge of International Committee for Harmonisation (ICH)/Good Clinical Practice (GCP).
• Computer skills and general computer literacy.
• Excellent English language skills (verbal and written)

Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves \xe2\x80\x93 feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK\'s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in \xe2\x80\x9cgsk.com\xe2\x80\x9d, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.